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FDA Drug Application 205474 by SOVEREIGN PHARMS

Application Number205474
Application Type New Drug Application
Sponsor ApplicantSOVEREIGN PHARMS
Most Recent Label Available Flag
Current Patent Flag
Action Type Approval
Chemical Type New combination
Therapeutic Potential Standard
Orphan Code 


  
Action TypeDuplicate CounterAction DateDocument TypeApplication Document IDSequence NumberDocument TitleDocument URLDocument Date
AP011/14/2014N41008000   http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2014/205474Orig1s000ltr.pdf 11/18/2014
AP011/14/2014N41042000   http://www.accessdata.fda.gov/drugsatfda_docs/label/2014/205474s000lbl.pdf 11/20/2014
AP011/14/2014N42434000   http://www.accessdata.fda.gov/drugsatfda_docs/nda/2014/205474Orig1s000TOC.cfm 4/6/2015
AP011/14/2014N42435000   http://www.accessdata.fda.gov/drugsatfda_docs/nda/2014/205474Orig1s000SumR.pdf 4/6/2015
AP06/19/2015SCM       
AP010/12/2016SCM       




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